(112 days)
Syngo Carbon Enterprise Access is indicated for display and rendering of medical data within healthcare institutions.
Syngo Carbon Enterprise Access is a software only medical device which is intended to be installed on recommended common IT Hardware. The hardware is not seen as part of the medical device. Syngo Carbon Enterprise Access is intended to be used in clinical image and result distribution for diagnostic purposes by trained medical professionals and provides standardized generic interfaces to connect to medical devices without controlling or altering their functions.
Syngo Carbon Enterprise Access provides an enterprise-wide web application for viewing DICOM, non-DICOM, multimedia data and clinical documents to facilitate image and result distribution.
The provided text is a 510(k) summary for the Syngo Carbon Enterprise Access (VA40A) device. It describes the device, its intended use, and compares it to a predicate device (Syngo Carbon Space VA30A). However, it explicitly states:
"No clinical studies were carried out for the product, all performance testing was conducted in a non-clinical fashion as part of verification and validation activities of the medical device."
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for a clinical study.
The document outlines "Non-clinical Performance Testing" and "Software Verification and Validation." These sections describe how the device's functionality was tested and validated to ensure it meets specifications and is substantially equivalent to the predicate device.
Here's what can be extracted about the "study" that proves the device meets "acceptance criteria" from a non-clinical performance testing and software verification/validation perspective:
1. Table of acceptance criteria and reported device performance:
The document broadly states that "The testing results support that all the software specifications have met the acceptance criteria" and "Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence." However, it does not provide a specific, detailed table of acceptance criteria and quantitative performance metrics for each criterion. It rather focuses on demonstrating equivalence through feature comparison and general assertions of testing success.
2. Sample size used for the test set and the data provenance:
The document mentions "non-clinical tests" and "software verification and validation testing." It does not specify the sample size for the test set or the provenance of the data used for this non-clinical testing (e.g., country of origin, retrospective or prospective). This testing would typically involve various types of simulated data, pre-recorded medical images, and functional tests rather than patient studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since no clinical studies were performed and the testing was non-clinical and technical, there's no mention of "experts" establishing ground truth in the way it would be done for a clinical performance study. The "ground truth" for non-clinical software testing would be derived from the product's functional specifications and expected outputs.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no clinical study with human interpretation/adjudication was conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable, as no clinical studies, especially MRMC studies, were conducted. The device is a medical image management and processing system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The testing was on the device's functionality as a standalone software, but this refers to its technical performance in image management and display, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this type of device and testing, the "ground truth" would be the functional specifications and expected behavior of the software based on its design documents. For example, if a function is to display a DICOM image, the ground truth is that the image should be displayed correctly according to DICOM standards. It's not based on clinical or pathological findings.
8. The sample size for the training set:
Not applicable. This device is a medical image management and processing system, not an AI/ML diagnostic algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
In summary, the provided document focuses on demonstrating substantial equivalence through a comparison of features with a predicate device and general non-clinical verification and validation activities, rather than a clinical performance study with defined acceptance criteria and statistical analysis of human or AI diagnostic performance.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Siemens Healthcare GmbH Vijay Ramadas Regulatory Affairs Manager Siemensstraße 3 FORCHHEIM, BAYERN 91301 GERMANY
May 23, 2024
Re: K240294
Trade/Device Name: Syngo Carbon Enterprise Access (VA40A) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: April 15, 2024 Received: April 15, 2024
Dear Vijay Ramadas:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica Lamb
Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
Syngo Carbon Enterprise Access (VA40A)
Indications for Use (Describe)
Syngo Carbon Enterprise Access is indicated for display and rendering of medical data within healthcare institutions
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots.
January 30, 2024
Traditional 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Submitter:
Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany
2. Establishment Registration Number: 3004977335
3. Contact Person:
Mr. Vijay Ramadas Regulatory Affairs Manager Siemens Healthcare GmbH, Siemensstr. 3 91301 Forchheim Germany
| E-mail: | vijay.ramadas@siemens-healthineers.com |
|---|---|
| Telephone: | +49 (172) 4324369 |
| Fax: | +49 (9191) 18-4404 |
4. Device Name and Classification
| Device/Trade Name: | Syngo Carbon Enterprise Access (VA40A) |
|---|---|
| Classification Panel: | Radiology Devices |
| Classification Number: | 21 CFR 892.2050 |
| Classification Name: | Medical Image Management and Processing System |
| Device Class: | Class II |
| Product Code: | LLZ |
5. Predicate Device(s):
| Device/Trade Name: | Syngo Carbon Space |
|---|---|
| 510(k) Clearance: | K230561 |
| Classification Panel: | Radiology Devices |
| Classification Number: | 21 CFR 892.2050 |
| Classification Name: | Medical Image Management and Processing System |
| Device Class: | Class II |
| Product Code: | LLZ |
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6. Device Description:
Syngo Carbon Enterprise Access is a software only medical device which is intended to be installed on recommended common IT Hardware. The hardware is not seen as part of the medical device. Syngo Carbon Enterprise Access is intended to be used in clinical image and result distribution for diagnostic purposes by trained medical professionals and provides standardized generic interfaces to connect to medical devices without controlling or altering their functions.
Syngo Carbon Enterprise Access provides an enterprise-wide web application for viewing DICOM, non-DICOM, multimedia data and clinical documents to facilitate image and result distribution.
7. Intended/Indications for use:
Syngo Carbon Enterprise Access is indicated for display and rendering of medical data within healthcare institutions.
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8. Summary of Differences between the Subject Device and the Predicate Device:
The differences between the subject device in this premarket notification and the predicate device are summarized in the following comparison table:
The predicate device is available in two variants;
- Syngo Carbon Space Diagnostic Workspace ।
- Syngo Carbon Space Physician Access (web component this is the predicate for the subject device) -
For readability and comparison purpose, the non-relevant items from the predicate of Syngo Carbon Space Diagnostic Workspace) are GREYED OUT and the relevant contents are retained
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| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
|---|---|---|---|---|
| Device nameand version | Syngo Carbon Enterprise AccessVA40A | Syngo Carbon Space VA30A(K230561) | New version of theproduct | NA |
| Manufacturer | Siemens Healthcare GmbH | Siemens Healthcare GmbH | Same | NA |
| Indications foruse | Syngo Carbon Enterprise Access isindicated for display and rendering ofmedical data within healthcareinstitutions. | Syngo Carbon Space is a softwareintended to display medical data and tosupport the review and analysis ofmedical images by trained medicalprofessionals.Syngo Carbon Space "DiagnosticWorkspace" is indicated for display,rendering, post-processing of medicaldata (mostly medical images) withinhealthcare institutions, for example, inthe field of Radiology, NuclearMedicine and Cardiology.Syngo Carbon Space "PhysicianAccess" is indicated for display andrendering of medical data withinhealthcare institutions. | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness |
| Contraindications | Syngo Carbon Enterprise Access is not intended for the diagnosis of digital mammography images and digital pathology reading.Syngo Carbon Enterprise Access is not intended to be used for diagnostic purpose on mobile devices in the United States of America (USA).Syngo Carbon Enterprise Access is not intended to be used as a sole basis for clinical decisions. | Syngo Carbon Space "Diagnostic Workspace" is not intended for diagnosis of digital mammography images.Syngo Carbon Space "Diagnostic Workspace" is not intended to be used as a sole basis for clinical decisions.Syngo Carbon Space "Physician Access" is not intended for diagnosis of digital mammography images.Syngo Carbon Space "Physician Access" is not intended to be used for diagnostic purpose on mobile devices in the United States of America (USA).Syngo Carbon Space "Physician Access" is not intended to be used as a sole basis for clinical decisions. | Same | NA |
| Software architecture | Syngo Carbon Enterprise Access is based on a client-server architecture | Syngo Carbon Space is based on a client-server architecture | Same | NA |
| Image communication | Standard network protocols like TCP/IP and standard communication protocol including DICOM (2016a) and non-DICOM objects. | Standard network protocols like TCP/IP and standard communication protocol including DICOM (2016a) and non-DICOM objects. Supports interfacing with HL7 (v2.5 / v2.3.1 / v2.3 / FHIR R4) | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Image displayalgorithms | MPR: MPR MIP: MIP, MinIP View AVG MED Invert Image | MPR: MPR, MPR Thick,MPR/MPR* MIP: MIP, MIP Thin MinIP View VRT*: Plain VRT, Adapt VRT,VRT Thin, Cinematic VRT Fused View * Invert Image * available in in DiagnosticWorkspace only | The additional AVGand MED are nonAI/ML Algorithms | This differencesbetween thepredicate device andthe subject devicedoesn't impact thesafety andeffectiveness of thesubject device as thenecessary measurestaken |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Measurement,Evaluation/InterpretationTools | • Distance (Distance line)• Pixel Lens• Angle• Ellipse Annotation• Polygon• Freehand• Capture | • Distance (Distance line, DistancePolyline)• Angle and Angle on stack*• 2D ROI (Circle, Freehand,Polygonal, Auto Contour) • 3D VOI (Sphere, Freehand) • Pixel Lens• Ranges (Parallel, Radial, RadialSliced, Curved, Spine) • Lesion Quantification• Assisted Perpendicular Tool• Automatic Organ Segmentation• Interactive Tissue Segmentation*• Time Curve, Time ROI*• SUV Measurement*• Automatic Anatomy Labeling(rib, spine) • Next Study/PreviousStudy/Nearline study• Change Geometry*• Snapshot• CT Lung Change*• MR General Reading*• Alpha Blending** Available in in DiagnosticWorkspace only | The tool set in thesubject device isenhanced. | This differencesbetween thepredicate device andthe subject devicedoesn't impact thesafety andeffectiveness of thesubject device as thenecessary measurestaken |
| Supportedobjectsfor display | DICOM image object display: | DICOM image object display: | Same | NA |
| • CR Image | • CR Image | Same | NA | |
| • CT Image | • CT Image | |||
| • DX Image | • DX Image | |||
| • ES Image | • ES Image | |||
| • GM Image | • GM Image | |||
| • MG Image | • MG Image | |||
| • MR Image | • MR Image | |||
| • NM Image | • NM Image | |||
| • PET Image | • PET Image | |||
| • OP/OPT Image | • OP/OPT Image | |||
| • RF Image | • RF Image | |||
| • RT IMAGE | • RT IMAGE | |||
| • SM (WSI) | • SM (WSI) | |||
| • XA Image | • XA Image | |||
| • US Image | • US Image | |||
| • Secondary capture objects | • Secondary capture objects | |||
| DICOM non-image object display: | DICOM non-image object display: | |||
| • ECG | • ECG | |||
| • Encapsulated PDF | • Encapsulated PDF | |||
| • PR | • PR | |||
| Non-DICOM file display: | Non-DICOM file display: | |||
| • Images: BMP, GIF, JPEG(JFIF), JPEG 2000, JPEG-LE,JPEG-LS, PCX, PNG, PNM,TIFF, WBMP | • Images: BMP, GIF, JPEG(JFIF), JPEG 2000, JPEG-LE,JPEG-LS, PCX, PNG, PNM,TIFF, WBMP | |||
| • Video: FLV, H.264, H.265,INDEO2, INDEO3, INDEO4,MPEG1, MPEG2, MPEG4. | • Video: FLV, H.264, H.265,INDEO2, INDEO3, INDEO4,MPEG1, MPEG2, MPEG4. | |||
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| VP8, VP9, WMV1, WMV2,WMV3Text Documents: CDA (XML), PDF | VP8, VP9, WMV1, WMV2,WMV3• Text Documents: CDA (XML), PDF | |||
| Operatingsystem | Server | Diagnostic Workspace | The operating system | This OperatingSystem and browser |
| Server Red Hat Enterprise Linux 9.x Client All operating systems that withsupport for the following HTML5-and JavaScript enabled browsers: Google Chrome ≥ 90 Microsoft Edge ≥ 90 Mozilla Firefox ≥ 91 Mozilla Firefox ESR ≥ 91 Apple Safari ≥ 15 Mobile device iPadOS ≥ 16 Apple Safari web browser >= 15 | Server Microsoft Windows Server 2019 Windows 10 Enterprise Red Hat Enterprise Linux 8.4 Client Microsoft Windows 10(Pro, Pro-Education, Enterprise) Microsoft Windows 11(Pro, Pro-Education,Enterprise) Physician Access Server Red Hat Enterprise Linux 8.4 Client All operating systems that withsupport for the following HTML5-and JavaScript enabled browsers: Google Chrome ≥ 90(tested and recommendedChrome 100) Microsoft Edge ≥ 90(tested and recommended:Edge 100) Mozilla Firefox ≥ 91 Mozilla Firefox ESR ≥ 91 Apple Safari ≥ 14 | for Linux, iOS andSafari browser versionis updated | version differencebetween thepredicate device andthe subject devicedoesn't impact thesafety andeffectiveness of thesubject device asnecessary measureshave been taken | |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness |
| Impact on Image Acquisition Devices | NoneSyngo Carbon Enterprise Access is a pure viewing software and it has no influence on the image acquisition devices. | Client – Mobile deviceiPadOS ≥ 14, Safari web browserNoneSyngo Carbon Space is a pure viewing and/or post-processing software and it has no influence on the image acquisition devices. | Same | NA |
| CAD Functionalities | NoneNo automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel. | NoneNo automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel. | Same | NA |
| Clinical condition the device is intended to diagnose, treat, or manage | No limitation on the clinical condition of the patient. | No limitation on the clinical condition of the patient. | Same | NA |
| Intended patient population | No limitation concerning the patient population (e.g., age, weight, health, condition) | No limitation concerning the patient population (e.g., age, weight, health, condition) | Same | NA |
| Site of the body the device is intended to be used | No limitation concerning region of body or tissue type | No limitation concerning region of body or tissue type | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Intended useenvironment | Syngo Carbon Enterprise Access isused in departmental environmentswithin healthcare institutions.For reading images certified monitorsare required (e.g., medical diagnosticdisplays). | Syngo Carbon Space "DiagnosticWorkspace" is used in Radiology,Nuclear Medicine and Cardiologyenvironments (e.g., darkened/ shadedrooms).Syngo Carbon Space "PhysicianAccess" is used in departmentalenvironments within healthcareinstitutions.For reading images certified monitorsare required (e.g., medical diagnosticdisplays). | Same | NA |
| Intendeduser(s) | Trained healthcare professionals | Trained healthcare professionals | Same | NA |
| Device Type | Software application | Software application | Same | NA |
| Softwarearchitecture | Syngo Carbon Enterprise Access isbased on a client-server architecture | Syngo Carbon Space is based on aclient-server architecture | Same | NA |
| Software self-test / checks | N/A - this is a browser basedapplication | Client installation is preventedautomatically in case if the systemdoesn't have the recommendedoperating system. Also during thelaunch of the client every time, thecompatibility to the server version ischecked and request toupdate/upgrade to client in case ofmismatch. | NA | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Cyber Security | • User access control• Audit Trail• Documentation of systemsecurity information, Networktraffic & Firewall control• Support of virus / malwareprotection• System Hardening (OS level andNetwork level) | • User access control• Audit Trail• Documentation of systemsecurity information, Networktraffic & Firewall control• Support of virus / malwareprotection• System Hardening (OS level andNetwork level) | Same | NA |
| Hardware | Hardware is not understood as part ofthe medical device but needs tocomply with the minimumrequirements as specified by SyngoCarbon Enterprise Access | Hardware is not understood as part ofthe medical device but needs tocomply with the minimumrequirements as specified by SyngoCarbon Space. | Same | NA |
| Graphical userinterface | Yes, with reduced color palette,clearer structure, and text labels onicons. Floating panels increases theuser friendliness as the user can movethe panels wherever they areconvenient with. | Yes, with reduced color palette,clearer structure, and text labels onicons. Floating panels increases theuser friendliness as the user can move | Same | NA |
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©Siemens Healthcare GmbH, 2024
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| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
|---|---|---|---|---|
| PatientBrowser | Search, browse & open data for display from syngo.share core & remote DICOM nodes Search, browse & open data for display from external XDS(-I) repository) Archive functionality (upload medical data to syngo.share core for archive) Document properties functions (metadata modification and tagging) Correct & re-arrange functions Restore (trigger fetch from archive) functions Distribution, export & sharing functions Inbox - access to medical data shared by other users | Search, browse & open data for display from syngo.share core & remote DICOM nodes Search, browse & open data for display from external XDS(-I) repository) ** Archive functionality (upload medical data to syngo.share core for archive) Document properties functions (metadata modification and tagging) Correct & re-arrange functions Restore (trigger fetch from archive) functions Distribution, export & sharing functions Inbox - access to medical data shared by other users ** **available in Physician Access only | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Seriesnavigator /DocumentPreview | Yes, with a fast overview of thedisplayed and not displayed data(series, images) of the loaded studies,quickly identify the relevantseries/images for reading, and bringdata (timepoints/series/images) intodisplay in an efficient manner(Drag&Drop).Study / Timepoints are marked withindividual colors for betteridentification. | Yes, with a fast overview of thedisplayed and not displayed data(series, images) of the loaded studies,identify not yet seen series/images*,quickly identify the relevantseries/images for reading, and bringdata (timepoints/series/images) intodisplay in an efficient manner(Drag&Drop).Study / Timepoints are marked withindividual colors for betteridentification.The Series Navigator is calledDocument Preview for PhysicianAccess.* available in in DiagnosticWorkspace only | Same | NA |
| Findings panel | Findings panel collectsmeasurements, annotations, andgraphical objects. Additionally, theuser can create new findings, editfindings. It also allows creation ofautomatic findings. | Findings panel collectsmeasurements, annotations, andgraphical objects. Additionally, theuser can create new findings, editfindings. It also allows creation ofautomatic findings. | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Reporting | No dedicated report creationfunctionality supported in SyngoCarbon Enterprise Access | No dedicated report creationfunctionality supported in SyngoCarbon Space.Structured findings can beautomatically transferred to externalthird-party reporting system via FHIRinterface for creation of structuredreport content [e.g. (Powerscribe [byNuance], SmartReports [by SmartReporting)] | Same | NA |
| ImageArchiving | Not applicable since Syngo CarbonEnterprise Access does not create dataor images that is transferred/stored. | Diagnostic Workspace:Syngo Carbon Space DiagnosticWorkspace does not store data orimages.Created results for a study (e.g.DICOM PR, SR objects) are stored insyngo.share core in context of theoriginal study. syngo.share core isresponsible for long term archiving ofthe original study and created results.Physician Access:Not applicable since Syngo CarbonSpace Physician Access does notcreate data or images that istransferred/stored | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Patient Jacket | Provides access to patient history –other studies of patient stored inremote DICOM nodes. Also providesa study content preview along withaccess to nearline studies and priorRIS reports | Provides access to patient history –other studies of patient stored insyngo.share core orremote DICOM nodes. Also provides | Same | NA |
| Optimization &preparation/SpatialOperation tools | Image Preview Zoom/Pan Synch, Align Windowing Flip (Horizontal, Vertical) Blow-up Scroll Movie Magnifier | Image Preview Zoom/Pan Fit to Segment*, Fit toAcquisition Size* Synch, Align Windowing Rotate (2D image or 3DVolume*) Flip (Horizontal, Vertical) Shutters On/Off* Blow-up Scroll Movie Clipping* Punching and Masking* Magnifier * available in in DiagnosticWorkspace only | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| AnnotationTool | • Text | • Arrow*• Marker*• Text* available in in DiagnosticWorkspace only | Same | NA |
| Printing | Provides printing functionality on apaper printer. | Diagnostic workspace:Provides printing functionality withable to review, modify the imagesalong with selecting the print sheetformat exposing then the DICOMprinter.Also, able to monitor the printingstatus and retry a printing task, ifneeded.Note• DICOM printer must be configured as DICOMnodes• Grayscale & color printing is supportedPhysician Access:Provides printing functionality on apaper printer. | Same | NA |
| Online helpsystem | Yes, with search, indexing, filtering,library function and documentcollections. | Yes, with search, indexing, filtering,library function and documentcollections. | Same | NA |
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9. Clinical Testing
No clinical studies were carried out for the product, all performance testing was conducted in a non-clinical fashion as part of verification and validation activities of the medical device
10. Non-clinical Performance Testing:
Non-clinical tests were conducted for the subject device during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Siemens Healthcare GmbH claims conformance to the following standards:
- ISO 14971 Third Edition 2019-12 -
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION -
- IEC 82304-1 Edition 1.0 2016-10 -
- IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION -
11. Software Verification and Validation:
Basic documentation as per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device Syngo Carbon Enterprise Access during product development.
The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
Siemens Healthcare GmbH conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Contained in this submission are our cybersecurity considerations as they relate to the device Syngo Carbon Enterprise Access.
12. Summary:
Performance tests were conducted to test the functionality of the device Syngo Carbon Enterprise Access. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
13. Safety and Effectiveness Information:
Software specifications, descriptions, hazard analysis, and labeling information are submitted in support of this premarket notification. The device labeling contains instructions for use with cautions to provide for safe and effective use of the device.
The results of the hazard analysis combined with the appropriate preventive measures taken indicate the device is of moderate level of concern, as per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
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14. Conclusion as to Substantial Equivalence:
The predicate device was cleared based on non-clinical supportive information. The comparison of technological characteristics, device hazards, non-clinical performance data, and software validation data demonstrates that the subject device performs comparably to and is as safe and effective as the predicate device that is currently marketed for the same intended use.
In summary, we are of the opinion that the subject device Syngo Carbon Enterprise Access, software version VA40A, does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device Syngo Carbon Space VA30A.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).